Senior QA Auditor – GCP Audits

IQVIA; Madrid; Presencial; EUR 60.000 - 90.000; Jornada completa

Descripción de la vacante

IQVIA is seeking a quality assurance auditor to plan and conduct independent clinical (GCP) audits across Europe. You will prepare reports for supervisors, operations staff, management, and customers, and provide consultation on regulations and corporate policies.

The role requires 5 years in pharma/QA audits, 30-50% travel, and experience in Investigator site audits. Extensive knowledge of QA processes and regulatory environments is essential for success at IQVIA.

Formación

• 5 years experience in pharmaceutical, technical, or related area, of which 3 years in Quality Assurance Audits.
• Travel 30-50% mainly in Europe.
• Experience in conduct of clinical trial Investigator site audits.
• Knowledge of regulatory environments and QA processes.

Responsabilidades

• Plan, schedule, conduct, report and close audit activities.
• Evaluate audit findings and prepare and distribute reports to stakeholders.
• Provide interpretation and consultation on regulations, guidelines and procedures.
• Lead QA initiatives/projects for quality improvements.
• Assist in training new Quality Assurance staff.
• Present educational programs on compliance procedures.

Conocimientos

GCP auditing

Quality assurance

Regulatory knowledge

Interpersonal skills

Training capability

Herramientas

eQMS

Descripción del empleo

Plan and conduct independent clinical (GCP) audits to assess compliance with regulations, guidelines, and operating procedures. Prepare and distribute reports of findings to supervisor, operations staff, management, and customers. Provide consultation in the interpretation of regulations, guidelines, policies, and procedures. Support management in the promotion and assessment of compliance with regulations, guidelines, and corporate policies.

Essential Functions

• Plan, schedule, conduct, report and close audit activities in any of the countries involved with IQVIA contracts to assess compliance with applicable regulations/guidelines, customer requirements, IQVIA SOPs, and project‑specific guidelines/instructions.
• Evaluate audit findings and prepare and distribute reports to operations staff, management, and customers.
• Provide interpretation and consultation to project teams on regulations, guidelines, compliance status, policies and procedures.
• Provide consultation to customers and monitors in the interpretation of audit observations and formulation of corrective action plans.
• Review, approve investigations, Root Cause Analysis (RCA), Corrective Action Prevention (CAPA), and Effectiveness Check (EC) plans and track till closure for quality events arising from audits, quality issues, inspections, or similar QA activities as assigned.
• Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements.
• Maintain the electronic quality management system (eQMS) and provide support in relation to the audit lifecycle.
• Lead, collaborate, and support QA initiatives/projects for quality and process improvements.
• Assist in training new Quality Assurance staff.
• Manage Quality Issues as required.
• Present educational programs and provide guidance to operational staff on compliance procedures.
• Perform pre‑inspection visits at sites, host audits/inspections, ensure proper conduct of customer‑initiated audits and mock regulatory inspections, and assist in regulatory facility inspections as assigned.

Qualifications

• The right candidate must be Certified to conduct audits in Italy in accordance with the Italian Decree of the Ministry of Health dated 15 Nov 2011.
• Travel 30‑50% mainly in Europe.
• 5 years experience in pharmaceutical, technical, or related area, of which 3 years in Quality Assurance Audits.
• Experience in the conduct of clinical trial Investigator site audits.
• Experience in the conduct of clinical study report/data management clinical trial audits is preferred.
• Knowledge of word‑processing, spreadsheet, and database applications.
• Extensive knowledge of pharmaceutical research and development processes and regulatory environments.
• Knowledge of quality assurance processes and procedures.
• Strong interpersonal skills.
• Excellent problem solving, risk analysis and negotiation skills.
• Strong training capabilities.
• Effective organization, communication, and team orientation skills.
• Ability to initiate assigned tasks and to work independently.
• Ability to manage multiple projects.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.

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